Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07677436

Effect of Virtual Reality-Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy

This randomized controlled trial aims to evaluate the effectiveness of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing adjuvant chemotherapy. Participants will be randomly assigned to either an intervention group receiving virtual reality-guided imagery in addition to routine care, or a control group receiving routine care

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital for Oncology and Hematology in Najaf Governorate

Najaf, Najaf Governorate, Iraq

Location contact

Thoalfokar Mohammed Al-Obaidi, PhD candidate

PRINCIPAL_INVESTIGATOR

thoalfokar mohammed abdalhussien, PhD candidate

CONTACT

[email protected]

07831476489

About this study

This study is a randomized controlled trial with a parallel-group design conducted to evaluate the effect of virtual reality-guided imagery in reducing pain, anxiety, and fatigue among female breast cancer patients undergoing chemotherapy at the National Hospital for Oncology and Hematology in Najaf Governorate, Iraq.

Eligible participants will be randomly allocated into two groups in a 1:1 ratio using block randomization with a fixed block size of four. The experimental group will receive virtual reality-guided imagery in addition to routine hospital care, while the control group will receive routine care only.

The intervention will be delivered during chemotherapy sessions over the study period. The content of the virtual reality-guided imagery will be designed to promote relaxation and psychological comfort, aiming to reduce symptom burden during chemotherapy administration.

Primary and secondary outcomes will be assessed using validated instruments. Pain intensity will be measured using the Numerical Rating Scale (NRS). Anxiety levels will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, and fatigue will be measured using the Brief Fatigue Inventory (BFI). Assessments will be conducted at baseline and after the intervention period.

Data will be analyzed by comparing changes in outcomes between the intervention and control groups to determine the effectiveness of virtual reality-guided imagery in improving symptom management among cancer patients undergoing chemotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged 18 years or older.
  • Histologically confirmed breast cancer.
  • Stage I, II, or III breast cancer.
  • Underwent surgery as the initial treatment and are scheduled to receive the first cycle of adjuvant chemotherapy, with or without biologic therapy (e.g., AC or TC regimens).
  • Able to read, write, and communicate.
  • Able and willing to use a virtual reality headset.
  • Able to provide written informed consent.

Exclusion criteria

  • Visual or hearing impairment that prevents the use of virtual reality.
  • Serious neurological or psychiatric disorders.
  • Current participation in other non-pharmacological interventions (e.g., meditation or relaxation therapy) that could influence the study outcomes.
  • Previous experience with virtual reality-guided imagery.
  • Use of analgesics, anxiolytics, or other medications during the intervention that may affect the study outcomes.

Treatment and study plan

Virtual Reality-Guided Imagery

Device

The intervention consists of immersive virtual reality-guided imagery delivered using a commercially available VR headset and pre-designed guided imagery software. Participants will wear the VR headset during chemotherapy sessions, which provides access to pre-recorded guided imagery programs.

These programs include standardized audiovisual content such as calming natural scenes, relaxation instructions, and breathing guidance designed to promote relaxation and distraction from pain, anxiety, and fatigue. The content is not developed by the researcher but is selected from existing validated or commercially available VR applications.

Each session will be administered under supervision during chemotherapy and in addition to routine hospital care. The intervention aims to reduce symptom burden by shifting the patient's attention away from treatment-related discomfort through immersive guided imagery experiences.

Other names: Immersive Virtual Reality, Guided imagery therapy

Primary outcomes

  1. Pain intensity

    Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

    Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 scale where higher scores indicate greater pain severity. The assessment will be conducted at baseline and after the intervention period to evaluate changes in pain levels between the intervention and control groups.

Secondary outcomes

  1. Anxiety level

    Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

    Anxiety levels will be assessed using the Arabic version of the Generalized Anxiety Disorder-7 (GAD-7) scale, a validated 7-item instrument with scores ranging from 0 to 21, where higher scores indicate greater anxiety severity.

  2. Fatigue level

    Time frame: Baseline; immediately after the first intervention; before the second intervention (Week 3); immediately after the second intervention (Week 3)

    Fatigue levels will be measured using the Arabic version of the Brief Fatigue Inventory (BFI-A), which assesses fatigue severity and its impact on daily functioning on a 0-10 scale. Both outcomes will be measured at baseline and after the intervention period to evaluate changes between the intervention and control groups.

Study contacts

Contact information is provided by the study sponsor or research team.

thulfiqar mohammed abdalhussien, PhD candidate

CONTACT

[email protected]

07831476489

Sponsors and collaborators

Lead sponsor

Thoalfokar Mohammed Al-Obaidi

Other

Registry information

Official study title

Effect of Virtual Reality Guided Imagery on Pain, Anxiety, and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

Acronym: VRGI-Chemo Tri

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.